Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium.

BACKGROUND AND AIMS: The European Union Medical Device Regulation 2017/745 challenges key stakeholders to follow transparent and rigorous approaches to the clinical evaluation of medical devices. The purpose of this study is a systematic evaluation of published clinical evidence underlying selected high-risk cardiovascular medical devices before and after market access in the European Union (CE-marking) between 2000 and 2021. METHODS: Pre-specified strategies were applied to identify published studies of prospective design evaluating 71 high-risk cardiovascular devices in seven different classes (bioresorbable coronary scaffolds, left atrial appendage occlusion devices, transcatheter aortic valve implantation systems, transcatheter mitral valve repair/replacement systems, surgical aortic and mitral heart valves, leadless pacemakers, subcutaneous implantable cardioverter-defibrillator). The search time span covered 20 years (2000-21). Details of study design, patient population, intervention(s), and primary outcome(s) were summarized and assessed with respect to timing of the corresponding CE-mark approval. RESULTS: At least one prospective clinical trial was identified for 70% (50/71) of the pre-specified devices. Overall, 473 reports of 308 prospectively designed studies (enrolling 97 886 individuals) were deemed eligible, including 81% (251/308) prospective non-randomized clinical trials (66 186 individuals) and 19% (57/308) randomized clinical trials (31 700 individuals). Pre-registration of the study protocol was available in 49% (150/308) studies, and 16% (48/308) had a peer-reviewed publicly available protocol. Device-related adverse events were evaluated in 82% (253/308) of studies. An outcome adjudication process was reported in 39% (120/308) of the studies. Sample size was larger for randomized in comparison to non-randomized trials (median of 304 vs. 100 individuals, P < .001). No randomized clinical trial published before CE-mark approval for any of the devices was identified. Non-randomized clinical trials were predominantly published after the corresponding CE-mark approval of the device under evaluation (89%, 224/251). Sample sizes were smaller for studies published before (median of 31 individuals) than after (median of 135 individuals) CE-mark approval (P < .001). Clinical trials with larger sample sizes (>50 individuals) and those with longer recruitment periods were more likely to be published after CE-mark approval, and were more frequent during the period 2016-21. CONCLUSIONS: The quantity and quality of publicly available data from prospective clinical investigations across selected categories of cardiovascular devices, before and after CE approval during the period 2000-21, were deemed insufficient. The majority of studies was non-randomized, with increased risk of bias, and performed in small populations without provision of power calculations, and none of the reviewed devices had randomized trial results published prior to CE-mark certification.

Phylogenetic Characterization of Orthohantavirus dobravaense (Dobrava Virus).

We report complete coding sequences of Orthohantavirus dobravaense (Dobrava virus) Igneada strains and phylogenetic characterization of all available complete coding sequences. Our analyses suggested separation of host-dependent lineages, followed by geographic clustering. Surveillance of orthohantaviruses using complete genomes would be useful for assessing public health threats from Dobrava virus.

EuMAR stakeholder engagement: an analysis of medically assisted reproduction (MAR) data collection practices in EU countries†.

STUDY QUESTION: What are the current national medically assisted reproduction (MAR) data collection systems across EU Member States, and how can these countries contribute to a unique, cycle-by-cycle registry for the European Monitoring of Medically Assisted Reproduction (EuMAR) project? SUMMARY ANSWER: The study identified significant variation in MAR data collection practices across Member States, with differences in data types, collection methods, and reporting requirements; the EuMAR project emerges as an opportunity to enhance data standardization and improve MAR data collection in the EU. WHAT IS KNOWN ALREADY: There is a need for new approaches in MAR data collection that include long-term and cross border follow-up. The EuMAR project intends to establish a unified, cycle-by-cycle registry of data on MAR treatments in EU countries, from which accurate cumulative outcomes can be calculated. STUDY DESIGN, SIZE, DURATION: This cross-sectional study involved a survey and interviews with stakeholders from 26 EU Member States conducted in 2023 over a period of seven months. PARTICIPANTS/MATERIALS, SETTING, METHODS: Representatives from national competent authorities and professional associations involved in MAR data collection in EU countries were invited to complete the survey and interviewed to assess current data flows, information requirements, and their interest in the EuMAR project. MAIN RESULTS AND THE ROLE OF CHANCE: Half of the participating countries reported having a national MAR registry with cycle-by-cycle data (n = 13), while 31% reported having a national registry with aggregated data (n = 8) and 19% reported having no national registry (n = 5). Of the countries with a national cycle-by-cycle registry, eight countries collect identifiable data, five countries collect pseudonymized data, and one country collects fully anonymized data. Informed consent is required in 10 countries. The main advantages that participants expected from a European registry like EuMAR were the possibility of obtaining national statistics in the absence of a national registry and improving the calculation of cumulative outcomes. LIMITATIONS, REASONS FOR CAUTION: The results of the study are based on self-reported data, which may be subject to bias, however, the validity of the collected information was verified with different means, including follow-up calls for clarifications and sharing final transcript reports. The feasibility of the proposed data flow models will be tested in a pilot study. WIDER IMPLICATIONS OF THE FINDINGS: Despite the heterogeneity of data collection practices across EU countries, the results show that stakeholders have high expectations of the benefits that the EuMAR registry can bring, namely the improvement of data consistency, cross-border comparability, and cumulative live birth rates, leading to better information for patients, health care providers and policy makers. STUDY FUNDING/COMPETING INTEREST(S): The EuMAR project was co-founded by ESHRE and the European Commission (101079865-EuMAR-EU4H-2021-PJ2). No competing interests were declared. TRIAL REGISTRATION NUMBER: N/A.

A Comparative Analysis of International Drug Price Negotiation Frameworks: An Interview Study of Key Stakeholders.

Policy Points Health care systems around the world rely on a range of methods to ensure the affordability of prescription drugs, including negotiating prices soon after drug approval and relying on formal clinical assessments that compare newly approved therapies with existing alternatives. The negotiation framework established under the Inflation Reduction Act is far more limited than other frameworks explored in this study. Adding elements from these frameworks could lead to more effective price negotiation in the United States. CONTEXT: In 2022, Congress passed the Inflation Reduction Act, which allowed Medicare, for the first time, to begin negotiating the prices for certain high-cost brand-name prescription drugs. Many other industrialized countries negotiate drug prices, and we sought to compare and contrast key features of the negotiation process across several health systems. We focused, in particular, on the criteria for selecting drugs for price negotiation, procedures for negotiation, factors that influence negotiated prices, and how prices are implemented. METHODS: We included four G7 countries in our analysis (Canada, France, Germany, and the United Kingdom [England]), two Benelux countries (Belgium and the Netherlands), and one Scandinavian country (Norway) with long-established frameworks for drug price negotiation. We also analyzed the Veterans Affairs Health System in the United States. For each system, we gathered relevant legislation, government publications, and guidelines to understand negotiation frameworks, and we reached out to key drug price negotiators in each system to conduct semistructured interviews. All interviews were recorded, transcribed, and coded, and data were analyzed based on an internal assessment tool that we developed. FINDINGS: All eight systems negotiate the prices of brand-name prescription drugs soon after approval and rely on formal clinical assessments that compare newly approved drugs with existing therapies. Systems in our study differed on characteristics such as whether the body performing clinical assessments is separate from the negotiating authority, how added health benefit is assessed, whether explicit willingness-to-pay thresholds are employed, and how specific approaches for priority disease areas are taken. CONCLUSIONS: High-income countries around the world adopt different approaches to conducting price negotiations on brand-name drugs but coalesce around a set of practices that will largely be absent from the current Medicare negotiation framework. US policymakers might consider adding some of these characteristics in the future to improve negotiation outcomes.

Guiding Principles for Evaluating Vaccines in Joint Health Technology Assessment in the European Union: Preparing for the European Union's Regulation on Health Technology Assessment for Vaccines.

OBJECTIVES: The appraisal of vaccines in the European Union (EU) currently involves many different decision-making bodies and processes. The objective of this study was to help inform the development of standardized methodology and vaccine-specific processes for use in the EU Regulation on health technology assessment (HTA). METHODS: Literature reviews and expert consultation were conducted to identify current practices and gaps related to vaccine appraisals and to develop guiding principles for the joint clinical assessment of vaccines. RESULTS: We found that significant variation exists across the EU member states in the decision-making processes when clinically evaluating vaccines. Three guiding principles consisting of 13 recommendations were developed to help inform the development of decision-making frameworks for the joint clinical assessment of vaccines in the EU: (1) support the creation of appropriate terminology and measurements for clinical appraisals of vaccines; (2) develop inclusive, timely, and transparent vaccine appraisal processes to support stronger evidence generation for vaccine decision making and appraisal; and (3) improve the collection and interoperability of real-world data, including robust surveillance, to foster evidence generation and support the standardization of vaccine clinical appraisals. CONCLUSIONS: Given the significance of vaccines for public health, there is an urgency to develop standardized and vaccine-specific methodologies and processes for use in the EU joint HTA framework. The proposed guiding principles could support the effective implementation of the EU Regulation on HTA for vaccines and have the potential to ensure consistent, transparent, and timely access to new vaccines in the EU.

Reference, calibration and referral laboratories - a look at current European provisions and beyond.

European Union (EU) regulations on in vitro diagnostics (IVD) and on serious cross-border threats to health provide for the establishment of European Reference Laboratories (EURLs) and their harmonization and cooperation with National Reference Laboratories (NRLs). While the EURLs under the IVD Regulation will be operational by 1 October 2024, the EURLs under the Regulation on serious cross-border threats to health will be operational by January 2025. Although NRLs may have been operating for a long time on the basis of national legislation, they should now cooperate with each other and with EURLs in a network of centers of excellence for the authorization and post-market surveillance of IVDs and for the epidemiological surveillance and control of communicable diseases. The term "reference laboratory" has long been used colloquially to refer to many kinds of laboratories, regardless of their tasks, competencies, responsibilities and designation. A literature search and analysis confirmed this by showing that a considerable proportion of scientific publications in 2024 use the term "reference laboratory" inappropriately. In order to clarify the roles and functioning of EURLs and NRLs, we have evaluated the relevant current EU provisions and compared the findings with those of reference laboratories designated by other organizations, calibration (reference) laboratories and referral laboratories, which are simply referred to as "reference laboratories". With the forthcoming implementation of the EU regulations, at least the goals of providing safe and high-quality IVDs and adequate public health surveillance for communicable diseases appear to be achievable.

Self-medication among general population in the European Union: prevalence and associated factors.

Self-medication (SM) forms an important part of public health strategy. Nonetheless, little research has been performed to understand the current state of self-medication in the European Union (EU). Utilizing data from the third wave of the European Health Interview Surveys, this study finds an estimated SM prevalence of 34.3% in the EU (95%CI = 34.1-34.5%; n = 255,758). SM prevalence, as well as SM prevalence inequality between men and women, varies substantially between EU member countries. Via multivariable analysis, we also identify a number of variables associated with SM, most notably the substantial impact of health systems on SM behavior (Adjusted Odds Ratio [AOR] = 4.00; 95% Confidence Interval [95%CI] = 3.81-4.21). Several demographics are also associated with greater SM prevalence, including those aged 25-44 (versus ages 75+: AOR = 1.21; 95%CI = 1.12-1.31), women (AOR = 1.74; 95%CI = 1.68-1.81), immigrants born in other EU states (AOR = 1.16; 95%CI = 1.04-1.30), those with higher education (AOR = 1.83; 95%CI = 1.60-2.09), and urban dwellers (AOR = 1.14; 95%CI = 1.04-1.30). Additionally, long-standing health problems (AOR = 1.39; 95%CI = 1.33-1.45), visits to doctors (both general practitioners and specialists) (AOR = 1.21, 95%CIs = 1.15-1.26, 1.17-1.26), and unmet needs for health care due to waiting lists (AOR = 1.38; 95%CI = 1.23-1.55) or inability to afford medical examinations/treatment (AOR = 1.27; 95%CI = 1.12-1.42) serve as conditioners for SM. We also find that smoking (AOR = 1.05; 95%CI = 1.01-1.10), vaping (AOR = 1.19; 95%CI = 1.06-1.32), drinking alcohol (AOR = 1.23; 95%CI = 1.19-1.28), and higher levels of physical activity (AOR = 1.27; 95%CI = 1.22-1.32) are factors associated with SM. Analysis of these variables reveals that though women self-medicate more than men, the patterns that govern their consumption are similar.

Mutual recognition of qualifications, health workforce migration, and graduate outcomes: a comparative mapping study of undergraduate dental education in Europe.

BACKGROUND: The resource needs of health services are served by the recognition of qualifications across borders which allows professionals to migrate between countries. The movement of dentists across the European Union (EU), especially into the United Kingdom (UK), has provided a valuable boost to workforce supply. Recent changes to policy recognising overseas qualifications have brought attention to the equivalence of qualifications awarded in EU countries. Professional regulators need to be confident that dentists who qualified elsewhere have the appropriate knowledge, skills and experience to practise safely and effectively. The aim of this study was to compare UK and EU dental curricula, identify any differences, and compare the extent of pre-qualification clinical experience. METHODS: This was a mixed methods study comprising a questionnaire and website searches to identify information about curricula, competences, and quality assurance arrangements in each country. The questionnaire was sent to organisations responsible for regulating dental education or dental practice in EU member states. This was supplemented with information obtained from website searches of stakeholder organisations for each country including regulators, professional associations, ministries, and providers of dental education. A map of dental training across the EU was created. RESULTS: National learning outcomes for dental education were identified for seven countries. No national outcomes were identified 13 countries; therefore, learning outcomes were mapped at institution level only. No information about learning outcomes was available for six countries. In one country, there is no basic dental training. Clinical skills and communication were generally well represented. Management and leadership were less represented. Only eight countries referenced a need for graduates to be aware of their own limitations. In most countries, quality assurance of dental education is not undertaken by dental organisations, but by national quality assurance agencies for higher education. In many cases, it was not possible to ascertain the extent of graduates' direct clinical experience with patients. CONCLUSIONS: The findings demonstrate considerable variation in learning outcomes for dental education between countries and institutions in Europe. This presents a challenge to decision-makers responsible for national recognition and accreditation of diverse qualifications across Europe to maintain a safe, capable, international workforce; but one that this comparison of programmes helps to address.

Integrating China in the International Consortium for Personalised Medicine: a position paper on innovation and digitalization in Personalized Medicine.

BACKGROUND: The advent of Personalized Medicine (PM) holds significant promise in revolutionizing healthcare by tailoring treatments to individual patients based on their data. However, its successful implementation requires the seamless integration of innovative technologies and presents formidable challenges in terms of sustainability. To tackle these challenges head-on, the International Consortium for Personalized Medicine (ICPerMed) was established, and the IC2PerMed project, as part of this consortium, seeks to foster collaboration between the European Union (EU) and China in the field of Personalized Medicine. Based on the results collected by the project, the objective of this study is to discern the key priorities for the implementation of Personalised Medicine concerning Information and Communication Technologies (ICT) and Big Data and digital solutions, with a particular emphasis on data management and protection. METHODS: A Delphi survey was conducted to gather expert's consensus on the main priorities for actions on Information and Communication Technologies (ICT) and Big Data and digital solutions in the field of Personalized Medicine. RESULTS: The survey identified seven priorities in the area of Big Data and digital solutions, including data interoperability, standards, security measures, and international partnerships. Additionally, twelve priorities were identified for the innovation-to-market process, emphasizing cost-effectiveness, need assessment, and value definition in resource allocation. CONCLUSIONS: The effective implementation of new technologies in Personalized Medicine research and practice is essential for the advancement of healthcare systems in both the European and Chinese contexts. The identified priorities play a pivotal role in promoting the sustainability of health systems and driving innovation in the implementation of Personalized Medicine. Addressing challenges related to data interoperability, standards, security, international collaboration, cost-effectiveness, and value assessment is of utmost importance in order to propel the progress of Personalized Medicine in healthcare systems.

The state of health in the European Union (EU-27) in 2019: a systematic analysis for the Global Burden of Disease study 2019.

BACKGROUND: The European Union (EU) faces many health-related challenges. Burden of diseases information and the resulting trends over time are essential for health planning. This paper reports estimates of disease burden in the EU and individual 27 EU countries in 2019, and compares them with those in 2010. METHODS: We used the Global Burden of Disease 2019 study estimates and 95% uncertainty intervals for the whole EU and each country to evaluate age-standardised death, years of life lost (YLLs), years lived with disability (YLDs) and disability-adjusted life years (DALYs) rates for Level 2 causes, as well as life expectancy and healthy life expectancy (HALE). RESULTS: In 2019, the age-standardised death and DALY rates in the EU were 465.8 deaths and 20,251.0 DALYs per 100,000 inhabitants, respectively. Between 2010 and 2019, there were significant decreases in age-standardised death and YLL rates across EU countries. However, YLD rates remained mainly unchanged. The largest decreases in age-standardised DALY rates were observed for "HIV/AIDS and sexually transmitted diseases" and "transport injuries" (each -19%). "Diabetes and kidney diseases" showed a significant increase for age-standardised DALY rates across the EU (3.5%). In addition, "mental disorders" showed an increasing age-standardised YLL rate (14.5%). CONCLUSIONS: There was a clear trend towards improvement in the overall health status of the EU but with differences between countries. EU health policymakers need to address the burden of diseases, paying specific attention to causes such as mental disorders. There are many opportunities for mutual learning among otherwise similar countries with different patterns of disease.

European policies for public health in border regions: no European mindset as yet.

BACKGROUND: The sudden emergence of COVID-19 in 2020 demonstrated that Europe was not prepared for a public health crisis like this pandemic. In the European Union, matters of health have remained primarily under the jurisdiction of individual Member States. However, certain events, such as the Kohll-Decker ruling on free mobility of health services and the COVID-19 pandemic, compelled the EU to address health matters in border regions. This study examines how EU policies address public health in border regions. To that end, we have drawn from border studies, a field that provides insight into the fluidity and complexity of borders in everyday life. Besides that we used constructivist policy studies as a lens for the analysis of EU policy documents. METHODS: A policy discourse analysis was conducted to explore how European policy addresses the development of a transnational, European public health in border regions. Key European policy documents published between 2002 and 2027 were analysed to understand how policies are constructed and problems are framed. The analysis was guided by research questions and the theoretical approach. RESULTS: The analysis reveals that, while having limited competences in the field of health care, the EU is slowly developing a rationale and a knowledge base to increase its competences in health care. It also shows that in the field of public health, the EU argues for addressing health determinants and promoting healthy lifestyles, though it does not address health promotion in border regions. The EU's authority in public health in border regions revolves primarily around addressing physical, biological and chemical threats rather than social health problems. CONCLUSION: Though the EU has carefully developed a transnational perspective on health care, the EU has not developed any authority with respect to transnational public health. Though public health and health promotion in border regions have been confronted with specific challenges, neither specific Member States nor the EU have a transnational collaborative perspective that does justice to the characteristics of border regions. When it comes to public health in border regions, there is no European mindset as yet.

Automating Wood Species Detection and Classification in Microscopic Images of Fibrous Materials with Deep Learning.

We have developed a methodology for the systematic generation of a large image dataset of macerated wood references, which we used to generate image data for nine hardwood genera. This is the basis for a substantial approach to automate, for the first time, the identification of hardwood species in microscopic images of fibrous materials by deep learning. Our methodology includes a flexible pipeline for easy annotation of vessel elements. We compare the performance of different neural network architectures and hyperparameters. Our proposed method performs similarly well to human experts. In the future, this will improve controls on global wood fiber product flows to protect forests.

A call to create integrated services to better address the needs of migrants who use drugs in Europe.

Each year, thousands of migrants enter the EU. Data on drug use in migrant populations are scarce and inconclusive. However, several risk factors make them particularly vulnerable to engaging in problematic drug use. In this perspective, we summarize the limited information that is available on migrants who use drugs and make a case as to why it is essential to improve access to health and social services, including harm reduction services, for this population. With this aim, we call for the co-creation of integrated services that better address the needs of migrants who use drugs in Europe.

Multi-risk instruments for emergency response: a multi-hazard and multi-risk assessment of the European Union's Solidarity and Emergency Aid Reserve.

Natural hazard-related disasters are on the rise and have significant impacts on the public and private sector. Different mechanisms and instruments exist on the pan-European level to deal with them, including the European Union Solidarity Fund (EUSF). Recently, the EUSF expanded its scope to incorporate public health emergencies and merged with the Emergency Aid Reserve to become the Solidarity and Emergency Aid Reserve. It therefore became a multi-hazard and multi-risk instrument to assist countries during the emergency phase of disasters. As different types of hazards and risks are drawing from the same fund there is concern about what capitalisation levels have to be assumed to make it sustainable. Hence, it is important to understand to which hazards and risks the fund is most exposed and whether there are regional differences within Europe. To address these issues, this paper takes a risk-based approach and estimates the capitalisation levels needed for major hazards and risks, noting regional differences across Europe.

European Health Union: An emergent reality.

In this article we argue that the Member States of the European Union (EU) have consistently, since its inception, developed a shared framework to measure, monitor and intervene to improve the health status of its population, while invoking the subsidiarity principle for the health sector. As a result, a European Health Union (EHU) has been emerging insidiously and consistently, following the concept of a system for health. Using the World Health Organisation Building Blocks Framework, we analyse the normative and institutional developments related to EU citizens' health that have created a de facto EHU. Developments towards an EHU remain unequally distributed among the different building blocks analysed. The existing EHU is the result of a fragmented and incremental process, mostly grounded in governance, health intelligence and services' development. Health crisis, the Commission's agenda-setting activities and market pressures have been the most important push factors for these step-by-step processes.

A Framework for Studying EU Health Policy through a Political Determinants of Health Lens: The Case of the European Health Union.

CONTEXT: The COVID-19 pandemic has highlighted how the European Union (EU) impacts national health systems and people's health. In November 2020, the European Commission launched the European Health Union (EHU) to better coordinate and maximize EU member states' abilities to deal with cross-border health threats. This article scrutinizes the early institutionalization of the EHU and its implications for EU health policy as a political determinant of health (PDoH). METHODS: The article explores how EU health policy may be appreciated from a PDoH perspective. It draws from EU documents and existing research to analyze the early-stage institutionalization of the EHU. The study complements this policy output-focused perspective with an outcome-based exploratory assessment of EU health policy as a PDoH focusing on three examples: joint vaccine procurement, health reforms and investments under the Recovery and Resilience Facility, and the development of a European Health Data Space. FINDINGS: The article shows that the policy change triggered by the EHU and the potential impact on citizens' health are not necessarily congruent. Modest change can have a potentially strong impact on health outcomes and vice versa. CONCLUSIONS: The article argues that the PDoH perspective provides a useful approach that is complementary to policy output-based perspectives, allowing for a more comprehensive assessment of the EU's role in health.

The EU as a Political Determinant of Global Health: The Case of Research and Development Incentives for Orphan Medicines and Biotechnology.

CONTEXT: The European Union (EU) governs global health through its constituent laws, institutions, actors, and policies. However, it is unclear whether or how these political factors interact to position the EU as a political determinant of global health. METHODS: The authors conduct a case study of the political factors influencing the adoption of the EU's Biotechnology Directive 98/44/EC and Orphan Medicines Regulation 141/2000. FINDINGS: The European Commission (EC) generally framed both of its proposals around economical and biomedical paradigms aligned with the needs of the EU's industry and patients, whereas the European Parliament (EP) contested some of these frames and proposed amendments supporting global access to medical products. The political factors influencing the adoption (in the Biotechnology Directive) or rejection (in the Orphan Regulation) of the EP's amendments include the complementarity between the EP and EC proposals, the EP's power in the intra- and interinstitutional negotiating process, the existence and support of civil society, and the alignment with member state priorities in the Council. CONCLUSIONS: In the late 1990s, the EU was an internally fragmented and politicized player concerning global health matters. These political factors should be considered for a coherent post-2022 EU strategy on global health.

Administering a Chill Pill? Better Regulation and the Potential for Regulatory Chill in European Union Health Policy.

The European Union's "good governance" program, known as Better Regulation, seeks to improve the quality of EU legislation by controlling the policy-making process. Despite its importance, it is rarely accounted for in the EU health policy literature. Seeking to address this gap, this article introduces Better Regulation in the context of health policy making. It conceptualizes a model of regulatory chill, drawn from the literature on international trade, to interrogate the impact of Better Regulation on EU policy-making processes. Using examples from the literature and data from a series of interviews with EU officials, it explores potential pathways of response and anticipatory chill, identifying direct enforcement of Better Regulation, its utilization by corporate actors, interpretation of its provision by officials, and feedback loops as possible routes of influence. The article argues that such an approach not only presents methodological challenges but also offers a valuable way of conceptualizing the relevance of political institutions in general, and Better Regulation specifically, for health. As part of broader calls for attention to the political determinants of health, the article's findings highlight the particular, and often overlooked, importance of metaregulatory policy frameworks.

Assessing Cross-Border Telemedicine Data Exchange in the European Union: A Call to Action.

Background: Telemedicine offers potential benefits for health care delivery. However, evidence of cross-border telemedicine data exchange within the European Union (EU) remains limited. The objective of this communication provides a brief outline of the regulatory framework, initiatives, and challenges associated with cross-border telemedicine data exchange in the EU, setting the stage for a comprehensive evidence assessment. Methods: We explore the current regulatory landscape (European Health Data Space), existing initiatives (the European Electronic Health Record Exchange Format), and interoperability challenges (e.g., legal, technical, semantic) facing EU cross-border telemedicine data exchange. Results: There is a need for thorough evidence assessment of cross-border telemedicine and related data movements. Conclusion: Understanding the current landscape of cross-border telemedicine is crucial. This article highlights the need for evidence assessment through a formal review to inform future research and policy initiatives in this domain.

A Comparison of European Union and Turkish Reports on the Statistics of Experimental Animal Use in Toxicity Testing.

The data on the number of animals used for experimental purposes, with a particular focus on regulatory toxicity studies, in Turkey and EU member states plus Norway (EU+), were compared for the period 2015 to 2020 (UK data after Brexit for 2020 were included too). The total number of listed vertebrates used for regulatory toxicity testing in the full 6-year reporting period in Turkey was 3.6% of that reported for the EU+. However, these numbers showed an increasing trend over the reporting period in Turkey, while the trend decreased in the EU+. In the top three most-used species for regulatory toxicology purposes in Turkey, 41% were fish (68,758 animals), followed by rats (29%; 49,975 animals), and then mice (20%; 33,292 animals). Turkey used low numbers of cats and dogs, while the corresponding number for the EU+ was more than 70-fold higher. Non-human primates were not used at all in Turkey, whereas about 34,000 were used in EU+ laboratories. The majority of toxicity tests (57%) performed in Turkey were categorised as 'Other' toxicity tests, and 27% were acute and sub-acute toxicity tests. Successful replacement alternatives (e.g. in vitro and in silico approaches) are already used in a wide range of research areas. However, although this new research and testing paradigm is underpinned by scientific evidence, the legislation and pace of acceptance of these new techniques in Turkey is considerably lagging behind other countries.